Trial results for a study investigating insulin sensitivity in Type 1 Diabetes were posted on 2025-10-28, indicating a statistically significant difference (p=0.01) in insulin sensitivity change between diet groups.
Background
Type 1 Diabetes is an autoimmune condition characterized by the body's inability to produce insulin, requiring lifelong insulin therapy. Research has explored various dietary approaches to manage the condition and potentially mitigate complications. One area of interest is the potential impact of dietary carbohydrate intake on insulin requirements and sensitivity, particularly in relation to concerns about iatrogenic hyperinsulinemia contributing to insulin resistance and endothelial dysfunction.
Trial design
This completed study, designated as Phase NA, enrolled 14 participants with Diabetes Mellitus, Type 1. The trial aimed to test the hypothesis that reducing insulin doses using a low carbohydrate diet (LCD) would be associated with improved insulin sensitivity and blood vessel health. Participants were likely assigned to either a standard carbohydrate diet or a low carbohydrate diet to assess these outcomes.
Key results
The study's key measurements reported the 'Change in Insulin Sensitivity Assessed as Glucose Infusion Rates'. For the Standard Carb Diet group, the median change was 8.6 mg/kg FFM/min. For the Low Carb Diet group, the median change was 8.1 mg/kg FFM/min. An ANOVA analysis, which reported the 'Median Difference (Final Values)', found a difference of 0.2 (95.0% Confidence Interval: -0.5 to 1.8), with a statistically significant p-value of 0.01.
What this means
The results indicate that the low carbohydrate diet group showed a numerically smaller median change in insulin sensitivity compared to the standard carbohydrate diet group. The statistically significant p-value of 0.01 for the 'Median Difference (Final Values)' suggests that this difference between the groups was unlikely due to chance. This finding does not support the hypothesis that a low carbohydrate diet would be associated with improved insulin sensitivity, as assessed by glucose infusion rates, when compared to a standard diet in this cohort. Clinicians and patients considering dietary strategies for Type 1 Diabetes may need to consider these results when evaluating the potential impact of carbohydrate restriction on insulin sensitivity.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public registry of clinical studies. The results for the study NCT04118374, titled 'A Study to Determine Iatrogenic Hyperinsulinemia's Contribution to Insulin Resistance and Endothelial Dysfunction in Type 1 Diabetes', were posted on 2025-10-28 on clinicaltrials.gov.